Pilot study to investigate the acceptance, feasibility, and efficacy of a hypnotherapeutic intervention for mothers of premature infants in daily farewell situations in the neonatal intensive care unit

Pilot study to investigate the acceptance, feasibility, and efficacy of a hypnotherapeutic intervention for mothers of premature infants in daily farewell situations in the neonatal intensive care unit - PANDA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039476

Enrollment

Registered

2026-03-02

Start date

2026-03-16

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mothers with preterm infants who need to be treated at the neonatal intensive care unit

Interventions

Group 1: Audio recording of a hypnotherapeutic farewell story by the study participants and playback of the audio recording before daily leaving the neonatal intensive care unit Group 2: Audio recordi

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Mothers of a premature baby (up to 32 weeks of pregnancy) who requires care in the neonatal intensive care unit - Planned duration of neonatal intensive care: 14 days or more - Mothers must be able to visit their child regularly (at least every other day)

Exclusion criteria

Exclusion criteria: - Insufficient knowledge of the German language - Child in palliative care or with shunt care - Participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
Efficacy of the intervention assessed using the following criteria (time/operationalisation): - Current stress levels, mental distress, anxiety, depression, worries and self-efficacy (1/visual analogue scale with colour scale) - Maternal stress experience (2+3/Parental Stressor Scale: Neonatal Intensive Care Unit; PSS:NICU_German/2-scales) - Symptoms of adjustment disorder (2+3/Adjustment Disorder-New Module 8 questionnaire; ADNM-8) - Postpartum depression symptoms (2+3/Edinburgh Postnatal Depression Scale; EPDS) - Maternal self-efficacy (2+3/Perceived Maternal Parenting Self-Efficacy Tool) - Quality of the mother-child relationship (2+3/Postpartum Bonding Questionnaire; PBQ-16) Timing of data assessment: (1) after playback of the audio recording on each of the 3 days following the audio recording (2) after the end of the intervention phase (after the last intervention) (3) at the follow-up time point (immediately before the child is discharged from the neonatal intensive care unit)	—

Measure

Time frame

Efficacy of the intervention assessed using the following criteria (time/operationalisation): - Current stress levels, mental distress, anxiety, depression, worries and self-efficacy (1/visual analogue scale with colour scale) - Maternal stress experience (2+3/Parental Stressor Scale: Neonatal Intensive Care Unit; PSS:NICU_German/2-scales) - Symptoms of adjustment disorder (2+3/Adjustment Disorder-New Module 8 questionnaire; ADNM-8) - Postpartum depression symptoms (2+3/Edinburgh Postnatal Depression Scale; EPDS) - Maternal self-efficacy (2+3/Perceived Maternal Parenting Self-Efficacy Tool) - Quality of the mother-child relationship (2+3/Postpartum Bonding Questionnaire; PBQ-16) Timing of data assessment: (1) after playback of the audio recording on each of the 3 days following the audio recording (2) after the end of the intervention phase (after the last intervention) (3) at the follow-up time point (immediately before the child is discharged from the neonatal intensive care unit)

—

Secondary

Measure	Time frame
Acceptance: - Percentage of mothers who decline to participate in the study after receiving study information - Percentage of mothers who decline to participate in the study after randomisation - Percentage of mothers who terminate study participation prematurely during the intervention phase Feasibility: - Percentage of audio playbacks performed according to protocol - Percentage of assessments performed according to protocol Safety: - Number of adverse events related to the intervention Assessment after the end of the intervention phase	—

Measure

Time frame

Acceptance: - Percentage of mothers who decline to participate in the study after receiving study information - Percentage of mothers who decline to participate in the study after randomisation - Percentage of mothers who terminate study participation prematurely during the intervention phase Feasibility: - Percentage of audio playbacks performed according to protocol - Percentage of assessments performed according to protocol Safety: - Number of adverse events related to the intervention Assessment after the end of the intervention phase

—

Countries

Germany

Contacts

Public ContactJenny Rosendahl

Universitätsklinikum Jena

jenny.rosendahl@med.uni-jena.de+4936419398038

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026